System for inner ear drug delivery via trans-round window membrane injection

ABSTRACT

The present disclosure discussed a handpiece for trans-canal delivery of a therapeutic substance to the inner ear. The handpiece can be inserted into the middle ear via a surgical tympanotomy approach. The handpiece can enable a controlled injection of a therapeutic substance directly through the round window membrane and into the inner ear. The direct delivery of the therapeutic substance to the inner ear can enable the delivery of a precise amount of therapeutic substance into the inner ear. Because the therapeutic substance is delivery directly to the inner ear the delivery of the therapeutic substance is not subject to limitations on molecule size and inconsistent diffusion rates that are present when therapeutic substances are diffused across the round window membrane.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of priority under 35 U.S.C. § 119 toU.S. Provisional Patent Application No. 62/353,324, filed Jun. 22, 2016,which is herein incorporated by reference in its entirety.

BACKGROUND OF THE DISCLOSURE

Delivery of therapeutics to the human inner ear can be challenging forclinicians. Two anatomic “windows” from the middle ear to the inner earexist, the oval and round windows. Each of these windows include asemi-permeable membrane. Drug delivery to the inner ear requires that atherapeutic substance cross one of these membranes.

SUMMARY OF THE DISCLOSURE

Inner ear drug delivery can use diffusion to cross one or both of themembranes of the anatomic windows to the inner ear. Relying on diffusionacross a membrane poses a number of difficulties. For example, diffusingtherapeutic substances across the membranes can introduce a lack ofprecision in terms of dose delivery. Relying on diffusion can also limitthe size and characteristics of therapeutic substance's moleculesbecause, for example, not all substances can diffuse across themembranes. Another example challenge is that the round window membranepermeability can vary between patients or during states of inflammation.The handpiece of the present disclosure can overcome these challenges bydelivering a therapeutic substance directly to the inner ear.

According to an aspect of the disclosure, a handpiece to deliver a fluidto an ear includes a tool shaft. The tool shaft includes a first distalend, a first proximal end, a first fluidic channel, and a firstlongitudinal axis. The handpiece also includes an angled portion. Theangled portion includes a second distal end, a second proximal endcoupled with the first distal end, a second fluidic channel incommunication with the first fluidic channel, and a second longitudinalaxis that defines an angle with the first longitudinal axis. The angledof the angled portion is configured for trans-canal positing of a tipportion at a round window. The handpiece also includes the tip portionthat projects from the angled portion. The tip portion includes anoutlet and a third fluidic channel in communication with the secondfluidic channel. The handpiece includes a collar that is coupled withthe tip portion a predetermined distance from the outlet. The collar isconfigured to seat with the round window and control a distance the tipportion projects into a cochlea.

The handpiece can also include a fluid reservoir in communication withthe outlet via the first fluidic channel, the second fluidic channel,and the third fluidic channel. The fluid reservoir further can include apierceable septum configured to enable filling of the fluid reservoir.

In some implementations, the handpiece can include a fluid reservoir.The handpiece can also include a self-contained pumping system that iscoupled with the tool shaft. The self-contained pumping system can beconfigured to pump a fluid from the fluid reservoir to the outlet.

The first fluidic channel, the second fluidic channel, and the thirdfluidic channel form a fluid channel. The fluid channel can be acontinuous fluid channel. The angled portion can be configured to detachfrom the tool shaft. The angled portion can be configured to rotate withrespect to the tool shaft. The tip portion can be configured to rotatewith respect to the angled portion. The tip portion can be configured todetach from the angled portion. The collar can be substantially domeshaped.

The first fluid channel can be encased within the tool shaft. The secondfluid channel can be encased within the angled portion. The third fluidchannel can be encased within the tip portion. Each of the first fluidchannel, the second fluid channel, and the third fluid channel can beencased in a sterilizable plastic or metal.

In some implementations, the angle between the tip portion and theangled portion can be between about 140° and about 170°. The tip portioncan project from the angled portion at an angle between about 75° andabout 130°. The tip portion can project from the angled portion at anangle between about 110° and about 120°.

According to an aspect of the disclosure, a method can include providinga handpiece. The handpiece can include a tool shaft. The tool shaftincludes a first distal end, a first proximal end, a first fluidicchannel, and a first longitudinal axis. The handpiece also includes anangled portion. The angled portion includes a second distal end, asecond proximal end coupled with the first distal end, a second fluidicchannel in communication with the first fluidic channel, and a secondlongitudinal axis that defines an angle with the first longitudinalaxis. The angled of the angled portion is configured for trans-canalpositing of a tip portion at a round window. The handpiece also includesthe tip portion that projects from the angled portion. The tip portionincludes an outlet and a third fluidic channel in communication with thesecond fluidic channel. The handpiece includes a collar that is coupledwith the tip portion a predetermined distance from the outlet. Thecollar is configured to seat with the round window and control adistance the tip portion projects into a cochlea. The method can includepiercing a round window membrane with the tip portion of the handpiece.The method can include flowing a fluid through the outlet and into acochlea via the first fluidic channel, the second fluidic channel, andthe third fluidic channel.

The method can include forming a ventilation hole in the stapesfootplate. The method can include flowing, by a self-contained pumpingsystem coupled with the tool shaft, the fluid from a reservoir. Themethod can include seating the collar in the round window. The methodcan include setting a rotational offset between the tip portion and theangled portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. Likereference numbers and designations in the various drawings indicate likeelements. For purposes of clarity, not every component may be labeled inevery drawing. In the drawings:

FIG. 1 illustrates an example handpiece delivering fluid to the innerear of a patient.

FIG. 2 illustrates a side view of the example handpiece illustrated inFIG. 1.

FIG. 3 illustrates a cross-sectional view of the example handpieceillustrated in FIG. 1.

FIG. 4 illustrates a side view of the example handpiece illustrated inFIG. 1.

FIG. 5 illustrates an example tip portion for the handpiece illustratedin FIG. 1.

FIG. 6 illustrates an example handpiece with a compression fitting.

FIG. 7 illustrates an enlarged view of the tip of the example handpieceillustrated in FIG. 1.

FIGS. 8A and 8B illustrates the tip of the example handpiece insertedinto a round window.

FIGS. 9 and 10 illustrate example fluid reservoirs coupled with theexample handpiece illustrated in FIG. 1.

FIG. 11 illustrates a block diagram of an example method to flow a fluidinto the cochlea with the example handpiece illustrated in FIG. 1.

DETAILED DESCRIPTION

The various concepts introduced above and discussed in greater detailbelow may be implemented in any of numerous ways, as the describedconcepts are not limited to any particular manner of implementation.Examples of specific implementations and applications are providedprimarily for illustrative purposes.

The present disclosure discussed a handpiece for transcanal delivery ofa therapeutic substance to the inner ear. The handpiece can be insertedinto the middle ear via a surgical tympanotomy approach. The handpiececan enable a controlled injection of a therapeutic substance directlythrough the round window membrane and into the inner ear. The directdelivery of the therapeutic substance to the inner ear can enable thedelivery of a precise amount of therapeutic substance into the innerear. Because the therapeutic substance is delivery directly to the innerear the delivery of the therapeutic substance is not subject tolimitations on molecule size and inconsistent diffusion rates that arepresent when therapeutic substances are diffused across the round windowmembrane.

FIG. 1 illustrates an example handpiece 100 delivering fluid to theinner ear of a patient. The fluid can be any therapeutic substance ortherapeutic agent. The handpiece 100 includes a tool shaft 102, anangled portion 104, and a tip portion 106. The tip portion 106 can alsoinclude a collar 108. The handpiece 100 is inserted into the ear canal110 of the patient for the transcanal delivery of fluid to the cochlea112 via the round window 114. The tip portion 106 can be used to piercethe round window membrane to enable fluid to be delivered to the cochlea112.

FIG. 2 illustrates a side view of the example handpiece 100. Thehandpiece 100 includes the tool shaft 102, the angled portion 104, andthe tip portion 106. A surgeon can use the tool shaft 102 to hold andmanipulate the handpiece 100 and position of the tip portion 106. Theouter surface of the tool shaft 102 can include knurling to enable abetter grip of the handpiece 100 by the surgeon. The tool shaft 102includes a proximal end 200 and a distal end 202. The tool shaft 102 canhave a diameter of about 4 mm, 5 mm, or about 6 mm. The tool shaft 102can have a length of between about 90 mm and about 150 mm, between about90 mm and about 130 mm, or between about 100 mm and about 120 mm. Insome implementations, the length of the tool shaft 102 is 110 mm.

The distal end of the tool shaft 102 is coupled with the proximal end204 of the angled portion 104. The tip portion 106 is coupled with thedistal end 206 of the angled portion 104. The angled portion 104 isangled to enable the tip portion 106 to traverse the ear canal in aminimally invasive procedure and reach the round window. The angledportion 104 forms an angle 208 between the tool shaft 102 and the tipportion 106. The angle 208 can be about 170° and about 90°, betweenabout 170° and about 110°, between about 170° and about 120°, betweenabout 170° and about 140°, or between about 165° and about 155°. Theangle 208 can be defined as the angle between a longitudinal axis of thetool shaft 102 and a longitudinal axis of the tip portion 106. The angle208 is configured to enable transcanal positing of the tip portion 106at a patient's round window. The angle 208 can be selected to enable asurgeon to position the tip portion 106 at the round window and providethe surgeon visual access to the ear canal.

The tip portion 106 can be coupled with the distal end 206 of the angledportion 104. The distal portion of the tip portion 106 can be angle. Theangle 210 can be between about 70° and about 140°, between about 75° andabout 130°, between about 90° and about 120°, between about 100° andabout 120°, or between about 110° and about 120°. For example, the angle210 can be about 105°, 106°, 107°, 108°, 109°, 110°, 111°, 112°, 113°,114°, 115°, 116°, 117°, 118°, 119°, or 120°. The angle 210 can beselected to position the distal portion of the tip portion 106substantially perpendicular to the round window when the handpiece 100is inserted through the ear canal. The angle 210 can be selected basedon the anatomical configuration of the patient's inner and middle ear.For example, the surgeon can select a handpiece 100 with an appropriateangle 210 based on the position and angle of the round window and theround window niche. In some implementations, the surgeon can determinewhich angle 210 to select using CT or MM images of the middle and innerear. The handpiece 100 can be manufactured with different angle 210configurations. In some implementations, the surgeon can bend the tipportion 106 to alter the angle 210 during a procedure.

The tip portion 106 can include a collar 108. The collar 108 can beconfigured to seat within the round window. The collar 108 can seal theround window once the tip portion 106 pierces the round window membrane.The collar 108 can also control the depth the end of the tip portion 106can be inserted into the cochlea. The collar 108 can include amedical-grade silicone. The collar 108 can be substantially domed orsemi-spherical in shape. The diameter of the collar 108, at the collar'swidest, can be between about 0.5 mm and about 3 mm, between about 0.5 mmand about 2.5 mm, between about 1 mm and about 2 mm, or between about1.5 mm and about 2 mm.

The handpiece 100 can have an overall length 212 between about 130 mmand about 170 mm, between about 140 mm and about 160 mm, or betweenabout 140 mm and about 150 mm. While described as different portions,the tool shaft 102, the angled portion 104, and the tip portion 106 caneach be manufactured as single or multiple pieces. For example, thehandpiece 100 can include one, two, or three separate pieces. Thehandpiece 100 can be separable at the interface between any of the toolshaft 102, the angled portion 104, and the tip portion 106. In someimplementations, the interface between the tool shaft 102, the angledportion 104, and the tip portion 106 does not indicate that the portionsare separable. For example, the tool shaft 102, the angled portion 104,and the tip portion 106 can be manufactured as a single piece. In otherimplementations, the angled portion 104 and the tool shaft 102 can forma first piece and the tip portion 106 can form a second piece. In someimplementations, the handpiece 100 is reusable. In otherimplementations, the handpiece 100 is disposable. The handpiece 100 canbe manufactured from medically-approved sterilizable materials. Forexample, the handpiece 100 can be manufactured from 316 stainless steelor a sterilizable plastic.

FIG. 3 illustrates a cross-sectional view of the example handpiece 100.The handpiece 100 includes a microfluidic channel 300. The microfluidicchannel 300 includes an inlet 302 and an outlet 304. The inlet 302 canbe coupled with a reservoir. The reservoir is described further inrelation to FIGS. 9 and 10. The microfluidic channel 300 can have agauge of about 22. The microfluidic channel's gauge can be between about12 and 28, between about 16 and about 24, between about 18 and about 22,or between about 20 and 22. The microfluidic channel 300 can have a deadvolume of between about 10 μL and about 25 between about 15 μL and about25 or between about 20 μL and about 25 μL.

The microfluidic channel 300 can include different portions. Forexample, each of the tool shaft 102, angled portion 104, and the tipportion 106 can include a different portion of the microfluidic channel300. The different portions can be a single channel, continuous channel.In some implementations, the microfluidic channel 300 is separable atthe interface between one or more of the portions. In someimplementations, the microfluidic channel portions are separable nearthe interface between the different portions of the handpiece 100. Forexample, the microfluidic channel portion within the tip portion 106 canextend past the tip portion 106 (as illustrated in FIG. 4) and themicrofluidic channel portion within the angled portion 104 can stopprior to the distal end 206, such that portion of the microfluidicchannel extending from the tip portion 106 can be received by the angledportion 104. In some implementations, the handpiece 100 can include aplurality of microfluidic channels 300. For example, the handpiece 100can include different microfluidic channels 300 for delivering differenttherapeutic agents. In some implementations, a second microfluidicchannel 300 can be used to evacuate fluid from the cochlea.

FIG. 4 illustrates a side view of the example handpiece 100. In someimplementations, one or more of the portions of the handpiece 100 areseparable from one another. FIG. 4 illustrates an example handpiece 100with a separable tip portion 106. The tip portion 106 can be separatedfrom the tool shaft 102 and the angled portion 104 to facilitatesterilization of the handpiece 100. The tip portion 106 can be separablefrom the angled portion 104 to enable the tip portion 106 to berecoupled with the angled portion 104 at a different rotational angle.The tip portion 106 can be rotated with respect to the angled portion104 without separating the tip portion 106 from the angled portion 104.The tip portion 106 can be rotated with respect to the angled portion104 to provide the surgeon with improved access to the round window. Forexample, the surgeon can adapt the default position of the tip portion106 to account for variability between patient anatomies. The handpiece100 can include gaskets or o-rings at the interface between theseparable portions. The separable portions can be coupled together withsnap-on connectors, friction-fit or press-fit connections, or Luer lockconnections.

FIG. 5 illustrates an example tip portion 106 for the example handpiece100. The tip portion 106 illustrated in FIG. 5 is separated from theangled portion 104 and the tool shaft 102 of the handpiece 100. The tipportion 106 can include a tip 500. The tip 500 can be portion of themicrofluidic channel 300 extending from the body of the tip portion 106.In some implementations, all of the tip portion 106 can be rotated withrespect to the angled portion 104. In other implementations, the tip 500can be rotated within the tip portion 106. In either example, the tip500 can be rotated from the position illustrated in FIG. 4 to a secondposition 502, illustrated by the dashed lines.

FIG. 6 illustrates an example handpiece 100 with a compression fitting600. The compression fitting 600 can be knurled nut. The compressionfitting 600 can couple the angled portion 104 with the tip portion 106.The compression fitting 600 can be loosened to enable the tip portion106 to rotate with respect to the angled portion 104. Once the surgeonselects a degree of rotation, the surgeon can tighten the compressionfitting 600 to lock the degree of rotation between the angled portion104 and the tip portion 106 in place. In other implementations, the tipportion 106 and the angled portion 104 can be held together with afriction fit that enables the tip portion 106 to be rotated with respectto the tip portion 106.

FIG. 7 illustrates an enlarged view of the tip 500 of the examplehandpiece 100. The tip 500 can include a needle end 700. The needle end700 includes the outlet 304. The needle end 700 can be a blunt end orcan be beveled to form a point. The needle end 700 can be configured topierce the round window membrane. The needle end 700 extends past thecollar 108 by a length between about 1 mm and about 4 mm, between about2 mm and about 3 mm, or between about 2.5 mm and about 3 mm. Forexample, the needle end 700 can have a length of 2.7 mm. The needle end700 can have a gauge size between about 25 and about 30, between about26 and about 30, or between about 27 and about 30. Once the collar 108is seated into the round window only the needle end 700 projects intothe cochlea. The collar 108 can control the depth the needle end 700projects into the cochlea. The needle end 700 can prevent the needle end700 from projecting too far into the cochlea. The needle end 700 canprevent the needle end 700 from projected too far into the cochlea anddamaging the cochlea. The collar 108 can properly position the outlet304 within the cochlea so that the therapeutic substance properlydisperses through the cochlea. For example, if the outlet 304 ispositioned too shallow into the cochlea, the therapeutic substance canconcentrate near the round window and not disperse through the cochlea.If the outlet 304 is position too deep into the cochlea, the needle end700 can cause damage or trauma to the cochlea. In some implementations,the tip 500 is manufactured from a malleable material such that asurgeon can bend the tip 500 to alter the angle 210. The collar 108 canbe coupled with the tip 500 with an adhesive. In some implementations,the tip 500 can include a groove in which the collar 108 is seated.

FIGS. 8A and 8B illustrate the tip 500 inserted into the round window.FIG. 8A illustrates the handpiece 100 inserted through the ear canalwith the tip 500 inserted into the round window 114. FIG. 8B illustratesan enlarged view, from FIG. 8A, of the tip 500 inserted into the roundwindow 114. The tip 500 can be used to pierce the round window membrane.The tip 500 can be inserted into the round window 114. The collar 108can be seated into the round window 114 and seal the round window 114 asfluid is injected into the cochlea 112. The collar 108 is tapered from adiameter smaller than the diameter of the round window 114 to a diameterthat is wider than the diameter of the round window 114. When the collar108 is depressed against the round window 114, the collar 108 canocclude the round window 114. The collar 108 can also be used to controlthe insertion depth of the tip 500 into the cochlea 112. For example,the collar 108 can prevent the tip 500 from being inserted into thecochlea past the collar 108. The portion of the collar 108 with adiameter wider than the diameter of the round window 114 cansubstantially stop the tip 500 from farther insertion of the tip 500into the cochlea 112. Moving the collar 108 towards the outlet 116 ofthe tip 500 reduces the depth to which the tip 500 can be inserted. Thecollar 118 can prevent the tip 500 from being inserted too far into thecochlea 112.

FIG. 9 illustrates an example fluid reservoir 900 coupled with theexample handpiece 100. The fluid reservoir 900 can be coupled with apump that pumps the fluid stored in the fluid reservoir 900 through themicrofluidic channel 300 of the handpiece 100 and out the handpiece'soutlet 304. The fluid reservoir 900 can be coupled to displacement pump,syringe, syringe pump, or other type of mechanical, electric-mechanical,hydraulic, or pneumatic-driven actuator. The inlet 302 of themicrofluidic channel 300 can coupled to the fluid reservoir 900 toenable the fluid to be introduced to the microfluidic channel 300. Insome implementations, the fluid reservoir 900 can be separable from thehandpiece 100. The fluid reservoir 900 can include a pierceable septumthat the inlet 302 pierces when a user attaches the fluid reservoir 900to the handpiece 100. In other implementations, the fluid reservoir 900can be a component of the handpiece 100 that is filled with a fluidprior to use. The fluid reservoir 900 can include a pierceable septumthrough which the fluid reservoir 900 is loaded. For example, a syringecan be loaded with the therapeutic substance. The syringe's needle canbe inserted through the pierceable septum and the therapeutic substanceinjected into the fluid reservoir 900. FIG. 10 illustrates an examplefluid reservoir 900 coupled with a handpiece 100. The fluid reservoir900 can include self-contained pumping system. The self-containedpumping system can pump a fluid from the fluid reservoir to the outlet304.

FIG. 11 illustrates a block diagram of an example method 1100 to flow afluid into the cochlea. The method 1100 can include providing ahandpiece (ACT 1102). The method 1100 can include piercing a roundwindow membrane (ACT 1104). The method 1100 can include flowing a fluidinto the cochlea (ACT 1106).

As set forth above, the method 1100 can include providing a handpiece(ACT 1102). The handpiece 100 can be any of the handpieces describedherein. For example, the handpiece 100 can include a tool shaft thatincludes a first distal end, a first proximal end, a first fluidicchannel, and a first longitudinal axis. The handpiece 100 can include anangled portion that can include a second distal end, a second proximalend coupled with the first distal end, a second fluidic channel incommunication with the first fluidic channel, and a second longitudinalaxis defining an obtuse angle with the first longitudinal axis. Thehandpiece 100 can include a tip portion projecting from the angledportion and comprising an outlet and a third fluidic channel incommunication with the second fluidic channel. The handpiece 100 caninclude a collar coupled with the tip portion.

The method 1100 can include piercing a round window membrane (ACT 1104).The round window membrane can be pierced with the tip portion of thehandpiece 100. For example, the provided handpiece 100 can be insertedthrough the ear canal. The handpiece's angled portion 104 can beconfigured to enable transcanal access of the round window. The tip 500of the tip portion 106 can be angled to position the needle end 700substantially perpendicular to the round window and round windowmembrane. The needle end 700 can be pressed against the round windowmembrane to pierce the round window membrane. The collar 108 can preventthe needle end 700 from projecting too far into the cochlea and causingdamage to the cochlea. The collar 108 can seat into the round window toseal the round window as the fluid is injected into the cochlea. Basedon the patient's anatomy, a surgeon can set a rotational offset betweenthe tip portion and the angled portion of the handpiece 100 to enablethe needle end 700 to access the round window. Also based on thepatient's anatomy, the surgeon can set the angle 210 between the needleend 700 and the tip portion such that the outlet 304 is positionedsubstantially perpendicular to the round window and round windowmembrane. CT or MRI scans of the patient's middle and inner ear can beconducted. The surgeon can measure the anatomical angles of thepatient's inner and middle ear to select the angle 210 of the tipportion 106. Also, based on the CT or MRI scans the surgeon can selectthe length of the needle end 700 such that when the collar 108 is seatedinto the round window the outlet 304 is properly positioned within thecochlea. The proper position of the outlet 304 can be a depth into thecochlea that does not cause damage to the cochlea but enablesdistribution of the fluid through the cochlea.

The method 1100 can include flowing a fluid into the cochlea (ACT 1106).A pump can pump the fluid from a fluid reservoir 900, through themicrofluidic channel 300, and into the cochlea via outlet 304. In someimplementations, the pump can be external to the handpiece 100. In otherimplementations, fluid reservoir 900 can include a self-contained pumpthat pumps the fluid from the fluid reservoir 900 to the outlet 304. Themethod 1100 can include drilling, or otherwise forming, a ventilationhole in the stapes footplate. The ventilation hole can enable therelease of pressure from the cochlea as the pump flows the fluid intothe cochlea.

CONCLUSION

While operations are depicted in the drawings in a particular order,such operations are not required to be performed in the particular ordershown or in sequential order, and all illustrated operations are notrequired to be performed. Actions described herein can be performed in adifferent order.

The separation of various system components does not require separationin all implementations, and the described program components can beincluded in a single hardware or software product.

Having now described some illustrative implementations, it is apparentthat the foregoing is illustrative and not limiting, having beenpresented by way of example. In particular, although many of theexamples presented herein involve specific combinations of method actsor system elements, those acts and those elements may be combined inother ways to accomplish the same objectives. Acts, elements andfeatures discussed in connection with one implementation are notintended to be excluded from a similar role in other implementations orimplementations.

The phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including” “comprising” “having” “containing” “involving”“characterized by” “characterized in that” and variations thereofherein, is meant to encompass the items listed thereafter, equivalentsthereof, and additional items, as well as alternate implementationsconsisting of the items listed thereafter exclusively. In oneimplementation, the systems and methods described herein consist of one,each combination of more than one, or all of the described elements,acts, or components.

As used herein, the term “about” and “substantially” will be understoodby persons of ordinary skill in the art and will vary to some extentdepending upon the context in which it is used. If there are uses of theterm which are not clear to persons of ordinary skill in the art giventhe context in which it is used, “about” will mean up to plus or minus10% of the particular term.

Any references to implementations or elements or acts of the systems andmethods herein referred to in the singular may also embraceimplementations including a plurality of these elements, and anyreferences in plural to any implementation or element or act herein mayalso embrace implementations including only a single element. Referencesin the singular or plural form are not intended to limit the presentlydisclosed systems or methods, their components, acts, or elements tosingle or plural configurations. References to any act or element beingbased on any information, act or element may include implementationswhere the act or element is based at least in part on any information,act, or element.

Any implementation disclosed herein may be combined with any otherimplementation or embodiment, and references to “an implementation,”“some implementations,” “one implementation” or the like are notnecessarily mutually exclusive and are intended to indicate that aparticular feature, structure, or characteristic described in connectionwith the implementation may be included in at least one implementationor embodiment. Such terms as used herein are not necessarily allreferring to the same implementation. Any implementation may be combinedwith any other implementation, inclusively or exclusively, in any mannerconsistent with the aspects and implementations disclosed herein.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

References to “or” may be construed as inclusive so that any termsdescribed using “or” may indicate any of a single, more than one, andall of the described terms. For example, a reference to “at least one of‘A’ and ‘B’” can include only ‘A’, only ‘B’, as well as both ‘A’ and‘B’. Such references used in conjunction with “comprising” or other openterminology can include additional items.

Where technical features in the drawings, detailed description or anyclaim are followed by reference signs, the reference signs have beenincluded to increase the intelligibility of the drawings, detaileddescription, and claims. Accordingly, neither the reference signs northeir absence have any limiting effect on the scope of any claimelements.

The systems and methods described herein may be embodied in otherspecific forms without departing from the characteristics thereof. Theforegoing implementations are illustrative rather than limiting of thedescribed systems and methods. Scope of the systems and methodsdescribed herein is thus indicated by the appended claims, rather thanthe foregoing description, and changes that come within the meaning andrange of equivalency of the claims are embraced therein.

What is claimed:
 1. A handpiece to deliver a fluid to an ear,comprising: a tool shaft comprising a first distal end, a first proximalend, a first fluidic channel, and a first longitudinal axis; an angledportion comprising a second distal end, a second proximal end coupledwith the first distal end, a second fluidic channel in communicationwith the first fluidic channel, and a second longitudinal axis definingan angle with the first longitudinal axis configured for trans-canalpositing of a tip portion at a round window; the tip portion projectingfrom the angled portion and comprising an outlet and a third fluidicchannel in communication with the second fluidic channel; and a collarcoupled with the tip portion a predetermined distance from the outlet,the collar configured to seat with the round window and control adistance the tip portion projects into a cochlea.
 2. The handpiece ofclaim 1, further comprising a fluid reservoir in communication with theoutlet via the first fluidic channel, the second fluidic channel, andthe third fluidic channel.
 3. The handpiece of claim 2, the fluidreservoir further comprising a pierceable septum configured to enablefilling of the fluid reservoir.
 4. The handpiece of claim 1, furthercomprising: a fluid reservoir; and a self-contained pumping systemcoupled with the tool shaft and configured to pump a fluid from thefluid reservoir to the outlet.
 5. The handpiece of claim 1, wherein thefirst fluidic channel, the second fluidic channel, and the third fluidicchannel form a fluid channel.
 6. The handpiece of claim 1, wherein theangled portion is configured to detach from the tool shaft.
 7. Thehandpiece of claim 1, wherein the angled portion is configured to rotatewith respect to the tool shaft.
 8. The handpiece of claim 1, wherein thetip portion is configured to rotate with respect to the angled portion.9. The handpiece of claim 1, wherein the tip portion is configured todetach from the angled portion.
 10. The handpiece of claim 1, whereinthe collar is substantially dome shaped.
 11. The handpiece of claim 1,wherein the first fluid channel is encased within the tool shaft, thesecond fluid channel is encased within the angled portion, and the thirdfluid channel is encased within the tip portion.
 12. The handpiece ofclaim 1, wherein each of the first fluid channel, the second fluidchannel, and the third fluid channel are encased in a sterilizableplastic.
 13. The handpiece of claim 1, wherein the angle is betweenabout 140° and about 170°.
 14. The handpiece of claim 1, wherein the tipportion projects from the angled portion at an angle between about 75°and about 130°.
 15. The handpiece of claim 1, wherein the tip portionprojects from the angled portion at an angle between about 110° andabout 120°.
 16. A method comprising: providing a handpiece comprising: atool shaft comprising a first distal end, a first proximal end, a firstfluidic channel, and a first longitudinal axis; an angled portioncomprising a second distal end, a second proximal end coupled with thefirst distal end, a second fluidic channel in communication with thefirst fluidic channel, and a second longitudinal axis defining an anglewith the first longitudinal axis configured for trans-canal positing ofa tip portion at a round window; the tip portion projecting from theangled portion and comprising an outlet and a third fluidic channel incommunication with the second fluidic channel; and a collar coupled withthe tip portion a predetermined distance from the outlet, the collarconfigured to seat with the round window and control a distance the tipportion projects into a cochlea; piercing a round window membrane withthe tip portion; and flowing a fluid through the outlet and into acochlea via the first fluidic channel, the second fluidic channel, andthe third fluidic channel fluidic channel.
 17. The method of claim 16,further comprising forming a ventilation hole in a stapes footplate. 18.The method of claim 16, further comprising flowing, by a self-containedpumping system coupled with the tool shaft, the fluid from a reservoir.19. The method of claim 16, further comprising seating the collar in theround window.
 20. The method of claim 16, further comprising setting arotational offset between the tip portion and the angled portion.